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IRCT20200617047808N1 IRCT 2020-11-26 Shahid Beheshti University of Medical Sciences Effect of oral shilajit pill on female sexual function and quality of life Effects of oral Shilajit tablet on sexual function and sexual quality of life among married women of reproductive age: A triple blind; randomized; controlled; clinical trial study 2020-11-05 anticipated 48 Complete https://irct.ir/trial/51845 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Research units of married women of childbearing age who are unlikely and easy to enter the study from the research community according to the entry and exit criteria of research units. In the first stage, the research units will be divided into two groups of intervention and control based on the inclusion and exit criteria of screening and then randomly block using quadruple random blocks. This method strikes a balance in the allocated samples. In this way, we first design blocks of 4 types of available probabilities, so that in each block there are two people from the intervention group and two people from the control group. The number of probabilities in this case will be equal to 6.AABB(1)-BBAA(2)-ABBA(3)- BAAB(4)- BABA(5)- ABAB(6)Then the list of available modes is prepared and numbered by the tutor and we sort the blocks based on random numbers from 1 to 6. Matte envelopes in the package will be used in numbered order to hide the allocation. The researcher randomly picks up the envelopes and then enters the research units into the sampling system in order, Blinding description: This study will be a phase 1 three-blind clinical trial with placebo control group. The method of blinding is that the researcher and the research units and statistical analysts will also be unaware of the type of drug used and the placebo drug will be prepared by the pharmacist in the same form and with a special code and will be provided to the research units. Participants and researchers will be unaware of the drug codes and only the pharmacist will determine the drug code and after collecting and completing the study, these codes will be decoded. 1 Performance and quality of women's sexual life. Intervention 1: Intervention group: The intervention group is the group that takes 200 mg shilajit tablets. Intervention 2: Control group: The control group is the group that will take the placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality
public shadab shahali
tarbiat modares university,Jalal Al-Ahmad Highway, Faculty of Medical Sciences
tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3811 shadab.shahali@modares.ac.ir tarbiat modares university scientific azam rahmani
Tehran - Tohid Square - Mirkhani St. - School of Nursing and Midwifery Tehran - Nursing and Midwifery Research Center
tehran Iran (Islamic Republic of) 6459 +98 21 6105 4566 arahmani@sina.tums.ac.ir دانشگاه علوم پزشکی تهران- مرکز تحقیقات مراقبت های پرستاری و مامایی Iran (Islamic Republic of) Iran (Islamic Republic of) Women aged 45-18 years Iranian and living in Tehran Literacy in Persian Husband monogamy and living with the spouse now and during the study Having sex in the last two months(According to the research unit) No known underlying disease (diabetes, hypertension, asthma, heart disease, thyroid, pelvic visceral prolapse, tumor, other medical diseases, hyperlipidemia ...) Do not have mental illness(According to the research unit or file) Couples not addicted to drugs and alcohol(According to the research unit or file) Do not use drugs that affect sexual function in the questionnaire (according to the research unit or file) Have not had a stressful accident in the past month (according to the research unit) Do not have a urinary tract infection (according to a recent research unit or test) No vaginitis, cervicitis, pelvic genital pain disorders, active wound or genital lesion that interferes with sexual intercourse (penetration) (according to the examination and according to the statement of the research unit or file) Has no history of being a rape victim (according to the research unit) Has no history of infertility (according to the research unit) No history of pelvic surgery (colpuraphy or correction according to the research unit or file) Not sensitive to shellac or its compounds (according to the research unit) Not pregnant or breastfeeding (according to the research unit) 18 years 45 years Female Not wanting to stay in the study Do not take Shilajet tablets regularly (use less than 80% of cases) Sensitivity to Shilajet pills or side effects during the study (according to the research unit) Creating an active wound or lesion in the genital area that interferes with sexual intercourse (penetration) during the intervention (according to the research unit) Consumption of drugs affecting sexual function during the intervention (according to the research unit) Experience of a stressful incident during the intervention (according to the research unit) Urinary tract infection, vaginitis, cervicitis, pelvic genital pain disorders, sexual abuse during the intervention (according to the research unit) Pregnancy during the intervention (according to the research unit or a positive pregnancy test) Treatment - Drugs Placebo Intervention group: The intervention group is the group that takes 200 mg shilajit tablets. Control group: The control group is the group that will take the placebo Sexual function. Timepoint: 3 times at intervals of 1 month. Method of measurement: Female Sexual Function Index ( FSFI Questionnaire). Sexual quality of life-Female. Timepoint: 3 times at intervals of 1 month. Method of measurement: sexual quality of life-Female (SQOL-F) Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-10-27 tarbiat modares university No.7. Jalal Al Ahmad Street, Tehran Tehran Tehran Iran (Islamic Republic of)